FDA.reportPublic FDA data

Tussin DM Max

Product NDC
0363-1043
11-digit product format
003631043
Labeler code
0363
Product ID
0363-1043_715748d5-52f0-471b-81a6-0cf2fe18880a
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-14
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tussin DM Max
Brand name suffix
NIGHTTIME
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/20mL
DOXYLAMINE SUCCINATE12.5 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, V9BI9B5YI2
Rxcui1115329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1043-19Tussin DM MaxNIGHTTIME1 in 1 CARTONSOLUTION14
0363-1043-19Tussin DM MaxNIGHTTIME237 mL in 1 BOTTLE, PLASTICSOLUTION2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1043TUSSIN DM MAX NIGHTTIME (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY]3Current NDC, 2 package rows20250430_d10a413e-22a6-4799-8367-5777831756a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNd10a413e-22a6-4799-8367-5777831756a94
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDd10a413e-22a6-4799-8367-5777831756a94
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYd10a413e-22a6-4799-8367-5777831756a94
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYd10a413e-22a6-4799-8367-5777831756a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0363-1043-19003631043191 BOTTLE, PLASTIC in 1 CARTON (0363-1043-19) / 237 mL in 1 BOTTLE, PLASTIC2024-05-14NoNoHistorical